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Twice-daily fixed-dose eye drops of lifitegrast plus perfluorohexyloctane for dry eye disease

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

Phase 2 Interventional Bausch & Lomb Incorporated · NCT07128628

This will test whether twice-daily eye drops that combine lifitegrast and perfluorohexyloctane help adults with dry eye disease feel better and improve measurable eye signs.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment423 (estimated)
Ages18 Years and up
SexAll
SponsorBausch & Lomb Incorporated Industry-sponsored
Locations32 sites (Phoenix, Arizona and 31 other locations)
Trial IDNCT07128628 on ClinicalTrials.gov

What this trial studies

This is a 4-week, randomized, double-masked, parallel-group, active-controlled multicenter trial comparing a fixed-dose combination of lifitegrast and perfluorohexyloctane to lifitegrast, perfluorohexyloctane, and vehicle given twice daily. Adults with at least a 6-month history of dry eye and consistent signs and symptoms at screening and baseline are enrolled and randomized to one of the study arms. Outcomes focus on changes in both patient-reported symptoms and clinical signs of dry eye over the 4-week treatment period. Study procedures include baseline and follow-up visits at participating eye clinics where standardized assessments are performed by masked staff.

Who should consider this trial

Good fit: Adults aged 18 or older with a history of dry eye in both eyes for at least 6 months and consistent dry eye signs and symptoms at screening and baseline who can follow study instructions are ideal candidates.

Not a fit: People with a known allergy or sensitivity to any study medication, those who do not meet the required signs or symptoms at screening, or who have ocular conditions excluded by the protocol are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the combination drops could reduce dry eye symptoms and improve clinical signs more than current single-agent or vehicle treatments.

How similar studies have performed: Lifitegrast is an approved treatment with prior evidence of benefit for dry eye, while combining it with perfluorohexyloctane is a newer approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

This study will include subjects who meet all of the following inclusion criteria:

* Voluntarily provide written informed consent
* ≥18 years of age
* Subject-reported history of DED OU for at least 6 months
* Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization
* The criteria for dry eye symptoms are met at both screening and baseline/randomization
* As needed (PRN) or scheduled use of non-prescription (OTC) artificial tear, gels, or lubricants for symptoms of dry eye within the past 30 days
* Able and willing to follow instructions, including participation in all trial assessments and visits

Exclusion Criteria:

This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):

* Known allergy or sensitivity to any study treatment (or any of its components)
* Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
* Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
* Use of any of any ocular therapies within 30 days.
* Unable or unwilling to stop current topical dry eye treatments

Additional criteria per protocol

Where this trial is running

Phoenix, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Dry Eye Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.